510(k) DEN170081
- Device
- MALDI Biotyper CA System
- Applicant
- Bruker Daltonik GmbH
- 510(k) number
- DEN170081
- Product code
- QBN
- Decision
- Unknown (DENG)
- Decision date
- 2018-04-20
- Date received
- 2017-09-29
- Regulation
- 866.3378
- Classification name
- Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Markus Kostrzewa
- Address
- Fahrenheitstrasse 4 Bremen DE 28359 28359
FDA Registration Numbers#
- 3010191749
- 1119779
- 9615037
- 3009288740
- 3010141591
- 9615754
- 1950204
- 3002444944
Source Documents#
510(k) summary PDF not indicated by FDA